Associate Scientist, Analytical Chemistry

Alcon Research•Durham, NC

1d•Onsite

About The Position

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As an Associate Scientist, Analytical Chemistry at our Durham facility. A typical day will include: Perform analysis of drug substance and drug product for potential ophthalmic medicines. For example, sample analysis, release, stability, structural analysis and/or IPC analysis of starting materials, intermediates, drug substance, and drug product materials. Analyze and evaluate materials and products at all stages of the pharmaceutical product development process. Generate analytical data for new and existing methods to trouble-shoot issues. Perform analytical chemistry in collaboration with others to develop and validate analytical methodology, including stability-indicating HPLC methods, GC methods, Karl Fischer for new drug substances and products. Perform and verify compendia methods Assist in the design and execution of clinical phase-appropriate method validation and stability protocols. Execute stability studies to support the development of new drug substances or drug products. Compile laboratory data. Assist laboratory investigations for aberrant and out-of-specification data. Author technical documents such as method development/validation reports, stability reports, and certificates of analysis with assistance. Maintain laboratory records and provide peer review of laboratory data. Schedule work activities with supervision and maintain laboratory supplies and equipment. Author and/or review standard operating procedures pertaining to analytical testing and reporting. Execute investigational studies in collaboration with others to address specific issues. Conduct work in compliance with cGMP, safety, and regulatory requirements. Assist in authoring Regulatory documents. Monitor and evaluates completion of tasks and projects. May assist in budget preparation for laboratory equipment.

Requirements

Bachelor’s Degree or Equivalent years of directly related experience (or high school +8 yrs; Assoc.+4 yrs)
The ability to fluently read, write, understand and communicate in English

Nice To Haves

Strong laboratory skills in analytical testing for small molecules.
Experience with HPLC/UPLC, GC, GC-with headspace, Karl Fischer, FT-IR, and other physical testing including pH, HIAC, viscosity.
The individual should be comfortable working in a fast-paced environment – able to rapidly flex activities and priorities.
This individual should be goal-oriented with excellent communication (written and oral) and organizational skills.
The individual must be able to work effectively in teams.
Experience with Empower software and electronic notebook (ELN) preferred.
Experience with analysis and/or analytical development for sterile solutions is preferred.
BS/BA in Chemistry or related discipline with at least 5-8 years of relevant experience.

Responsibilities

Perform analysis of drug substance and drug product for potential ophthalmic medicines.
Sample analysis, release, stability, structural analysis and/or IPC analysis of starting materials, intermediates, drug substance, and drug product materials.
Analyze and evaluate materials and products at all stages of the pharmaceutical product development process.
Generate analytical data for new and existing methods to trouble-shoot issues.
Perform analytical chemistry in collaboration with others to develop and validate analytical methodology, including stability-indicating HPLC methods, GC methods, Karl Fischer for new drug substances and products.
Perform and verify compendia methods.
Assist in the design and execution of clinical phase-appropriate method validation and stability protocols.
Execute stability studies to support the development of new drug substances or drug products.
Compile laboratory data.
Assist laboratory investigations for aberrant and out-of-specification data.
Author technical documents such as method development/validation reports, stability reports, and certificates of analysis with assistance.
Maintain laboratory records and provide peer review of laboratory data.
Schedule work activities with supervision and maintain laboratory supplies and equipment.
Author and/or review standard operating procedures pertaining to analytical testing and reporting.
Execute investigational studies in collaboration with others to address specific issues.
Conduct work in compliance with cGMP, safety, and regulatory requirements.
Assist in authoring Regulatory documents.
Monitor and evaluates completion of tasks and projects.
May assist in budget preparation for laboratory equipment.